MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM

Model Number CNH-G01-000

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Perforation (2001)

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "perforation" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Contact of electrosurgical components with other components may result in injury to the patient and/or operator as well as damage to the device and/or endoscope.Verify compatibility of endoscopic instruments and accessories and ensure performance is not compromised.Precautions the system may only be used if purchased from apollo endosurgery, inc.Or one of its authorized agents.With the endoscopic suturing system installed, the endoscope's primary channel effectively becomes a 3.2 mm channel.Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: pharyngeal, colonic and/or esophageal perforation.Additional information: the device has not been returned for analysis.The investigator determined that a device history record (dhr) review is not required for this complaint, as there are no other complaints against this lot number, af04665.

Event Description

Wire remained in patient with the help of apc the wire was removed.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 12/may/2022.A device history record (dhr) review was performed for this complaint as it's a reportable event.The subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against this lot number, af04665 device evaluation summary: the device was returned to the apollo device analysis laboratory on (b)(6)/2022.A cinch was returned dismantled without the plunger.Prior to decontamination, engineering visually inspected the device.There are no manufacturing abnormalities observed.The wire broke below the handle and the handle to wire is still intact.The complaint has been verified as the device was returned damaged; however, the root cause is unknown as several factors could contribute to the reported event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 13802294
• MDR Text Key: 291863718
• Report Number: 3006722112-2022-00030
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020671
• UDI-Public: (01)10811955020671(17)20240729(11)20210729(10)AF04665
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF04665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female